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LY4064809

Phase 3

Breast Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Jun 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment920
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07174336A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)PHASE3 RECRUITING 920 — — Dec 22, 2025May 1, 2033Jun 4, 2026327 United States, Argentina +16
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Study Endpoints
Primary Endpoints
(Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR)
Baseline through disease progression or death (Estimated up to 5 years)

As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1

(Part 2): Progression-Free Survival
Baseline to objective progression or death due to any cause (Estimated up to 5 years)

Investigator-assessed

Secondary Endpoints
(Part 1): Disease Control Rate (DCR)
Baseline through measured progressive disease (Estimated up to 5 years)
(Part 1): Time to Response (TTR)
Baseline until the date that measurement criteria for CR or PR (whichever is first recorded) are first met (Estimated as approximately 5 years)
(Parts 1 and 2): Duration of Response (DOR)
Date of CR or PR to date of objective disease progression or death due to any cause (Estimated up to 5 years)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 1)EXPERIMENTALLY4064809 given orally in one of two doses in combination with investigator's choice of CDK4/6 inhibitor given orally and ET given orally or intramuscularly
LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2)EXPERIMENTALLY4064809 given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly
Placebo + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2)PLACEBO_COMPARATORPlacebo given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly
Interventions
NameTypeDescription
LY4064809DRUGAdministered orally
PlaceboDRUGAdministered orally
RibociclibDRUGAdministered orally
PalbociclibDRUGAdministered orally
AbemaciclibDRUGAdministered orally
AnastrozoleDRUGAdministered orally
LetrozoleDRUGAdministered orally
ExemestaneDRUGAdministered orally
FulvestrantDRUGAdministered intramuscular
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites327

Inclusion Criteria: * Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * If assigned female at birth, pre-/peri- and postmenopausal stat...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaChinaFranceGermanyGreeceIrelandItalyJapanSouth KoreaSpainTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT07174336lastUpdatePostDate: changed
LOWJun 4, 2026NCT07174336lastUpdatePostDate: changed
LOWJun 4, 2026NCT07174336lastUpdatePostDate: changed
LOWJun 4, 2026NCT07174336lastUpdatePostDate: changed
LOWMay 26, 2026NCT07174336primaryCompletionDate: changed
LOWMay 24, 2026NCT07174336studyFirstPostDate: changed